Tildrakizumab for Genital Psoriasis

Not currently recruiting at 68 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sun Pharmaceutical Industries Limited

Must not be taking: Systemic anti-infectives

Disqualifiers: Erythrodermic psoriasis, Pustular psoriasis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called tildrakizumab, a monoclonal antibody, to evaluate its effectiveness and safety for individuals with moderate to severe genital psoriasis. Genital psoriasis causes red, itchy, and scaly patches in the genital area. The study includes two groups: one receiving tildrakizumab and the other a placebo, an inactive look-alike treatment. Suitable candidates for this trial have moderate to severe genital psoriasis not well-managed with creams or ointments and also have psoriasis patches elsewhere on their body. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tildrakizumab is likely to be safe for humans?

Research has shown that tildrakizumab is generally easy for patients to handle. In one study on genital psoriasis, participants reported no negative side effects after 28 weeks of treatment, suggesting the treatment is safe for most people. Another study found that tildrakizumab significantly improved patients' conditions without raising safety concerns.

While these results are encouraging, it's important to remember that everyone’s body is different. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for genital psoriasis?

Most treatments for genital psoriasis involve topical steroids or vitamin D analogs. However, Tildrakizumab is unique because it targets a specific part of the immune system, the interleukin-23 (IL-23) pathway. This pathway plays a major role in the inflammation seen in psoriasis. By specifically blocking IL-23, Tildrakizumab may offer a more targeted and potentially more effective approach to managing the condition. Researchers are excited about this treatment because it could mean fewer side effects and longer-lasting remission compared to traditional therapies.

What evidence suggests that tildrakizumab might be an effective treatment for genital psoriasis?

Research has shown that tildrakizumab, which participants in this trial may receive, effectively treats genital psoriasis. In a real-world study, it significantly improved symptoms for patients with psoriasis in sensitive areas, including the genital region. Another study found that after 28 weeks, nearly all signs of genital psoriasis disappeared, with a 93.9% improvement in skin condition scores. These results suggest that tildrakizumab can greatly reduce the severity of genital psoriasis for most patients. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe genital psoriasis, often not well-managed by topical treatments. Participants should have less than 10% body surface area affected by non-genital plaque psoriasis and no active tuberculosis. They must understand the trial's risks, agree to follow its rules, and provide written consent.

Inclusion Criteria

Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines

I have moderate to severe genital psoriasis.

I have psoriasis on parts of my body other than genitals covering 1% or more of my skin.

Exclusion Criteria

I don't have any health conditions that could make this study unsafe for me.

I am scheduled for surgery before the Week 16 check-up for a condition I had before treatment.

My psoriasis is not mainly plaque type but one of the other forms like erythrodermic or pustular.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous tildrakizumab or placebo for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tildrakizumab

Trial Overview The study tests Tildrakizumab's effectiveness and safety against a placebo in treating genital psoriasis. It's a phase 3 trial where participants receive either the actual drug or a placebo through subcutaneous injections.

How Is the Trial Designed?

Group I: Tildrakizumab 100 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Published Research Related to This Trial

Tildrakizumab demonstrated significant efficacy in treating moderate-to-severe plaque psoriasis, with 62.3% of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12, compared to only 5.6% in the placebo group.

The efficacy of tildrakizumab increased over time, with better responses observed in patients with lower body weight and those receiving the 200 mg dose, indicating that body weight may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. Papp, KA., Reich, K., Blauvelt, A., et al.[2020]

In a 52-week study involving 237 adults with moderate-to-severe plaque psoriasis, tildrakizumab demonstrated high efficacy, with 90.91% of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) and 58.68% achieving complete skin clearance (PASI 100) by Week 52.

The safety profile of tildrakizumab was favorable, with no significant adverse events reported, and no patients had to discontinue treatment due to side effects, indicating it is a well-tolerated option for psoriasis management in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). Narcisi, A., Valenti, M., Gargiulo, L., et al.[2023]

In a study of 190 patients with moderate-to-severe plaque psoriasis treated with tildrakizumab for 24 weeks, there was an impressive 88.79% reduction in the Psoriasis Area and Severity Index (PASI), indicating significant effectiveness in managing the condition.

The treatment was found to be safe, with only a 5.9% rate of adverse events, primarily infections, and no significant differences in effectiveness based on factors like gender or prior biological therapy exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group. Berenguer-Ruiz, S., Aparicio-Domínguez, M., Herranz-Pinto, P., et al.[2023]

In a study of 51 patients with moderate-to-severe plaque psoriasis who had previously failed biologic treatments, tildrakizumab showed significant effectiveness, with a marked reduction in the Psoriasis Area Severity Index (PASI) score from 19.2 at baseline to 0.6 at 48 weeks (P < 0.001).

The treatment also led to substantial improvements in Body Surface Area (BSA) and Dermatology Life Quality Index (DLQI) scores, indicating enhanced quality of life for patients, with significant results observed at both 12 and 48 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. Di Brizzi, EV., Buononato, D., Benvenuto, P., et al.[2023]

In the TRIBUTE study involving 177 adult patients with moderate-to-severe plaque psoriasis, treatment with Tildrakizumab (TIL) 100 mg for 24 weeks resulted in significant improvements in psoriasis severity, with 88.4% of patients achieving a PASI score of ≤3 and 92.5% achieving PASI 75.

The treatment also led to notable enhancements in health-related quality of life, including reduced pruritus, pain, and improved sleep, with a high patient satisfaction score (mean TSQM score of 80.5), and a favorable safety profile with only one serious adverse event reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. Costanzo, A., Llamas-Velasco, M., Fabbrocini, G., et al.[2023]

Tildrakizumab, a monoclonal antibody targeting IL-23, has shown significant efficacy in treating moderate-to-severe chronic plaque psoriasis, outperforming placebo and etanercept in clinical trials, with effects increasing up to 28 weeks and sustained efficacy for up to 3 years.

The safety profile of tildrakizumab is favorable, with good tolerability and only a slightly higher incidence of nasopharyngitis reported, indicating it is a safe option for patients with psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis. Näslund-Koch, C., Zachariae, C., Skov, L.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219165/

52-week Interim Data of the Phase IV Positive Study The results of the study showed that within 16 weeks of treatment, tildrakizumab quickly improved the psychological well-being of the people ...

2. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2025/58926.pdf

6881 Tildrakizumab significantly improves genital psoriasis ... Tildrakizumab significantly improved genital psoriasis in a real-world study evaluating treatment effectiveness in patients with psoriasis in high-impact areas.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06029257?term=Ilumya&rank=6

A Study of Tildrakizumab in the Treatment of Genital ... The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after ...

4. mdpi.com mdpi.com/2077-0383/11/9/2631

Scalp, Nail, Palmoplantar and Genital Psoriasis After 28 weeks, sPGA-G score decreased by 93.9%, leading to almost complete remission of genital psoriasis without any adverse events reported.

5. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2024.2420825

Full article: Effectiveness of tildrakizumab 200 mg After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively).

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-tildrakizumab-for-patients-with-moderate-to-severe-genital-psoriasis/

Study on the Effectiveness and Safety of Tildrakizumab ... The purpose of the study is to assess how well tildrakizumab works in reducing the symptoms of genital psoriasis over a period of 16 weeks.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9100809/

Scalp, Nail, Palmoplantar and Genital Psoriasis After 28 weeks, sPGA-G score decreased by 93.9%, leading to almost complete remission of genital psoriasis without any adverse events reported.

8. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2025/58910.pdf

Abstract N°: 6865 Tildrakizumab significantly improves ... Tildrakizumab significantly improves clinical outcomes in patients with psoriasis in high impact areas: 52- week interim data of the phase IV ...